Device and Method for Simple Meal Announcements for Automated Medication Delivery Systems Related Applications

Abstract

Disclosed are methods and devices configured to respond to changes in a user's blood glucose caused by the ingestion of a meal. The ingestion of a meal can be signaled by user input or by a meal detection algorithm that does not require any user input. The responsive devices and methods determine a carbohydrate-compensated insulin dose based on the user's blood glucose history, external data related to the user's meal history, or the user's response to a previous carbohydrate-compensated insulin dose. Additionally, a correction insulin dose can be calculated to cover the gap between the starting blood glucose and the target blood glucose. The user's response to the sum of the carbohydrate-compensated insulin dose and the correction insulin dose can be delivered. Based on the user's response, the disclosed examples can determine a modification to the carbohydrate-compensated insulin dose, the correction insulin dose, or both.

Description

[Technical Field]

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 119,055, filed November 30, 2020, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] Currently, state-of-the-art meal bolus calculators require users to input their estimated carbohydrate intake. Meal size and estimation error vary from person to person. The maximum estimation error can be around ±25g.

[0003] Some hybrid automated insulin delivery systems may require the user to manually prescribe insulin doses to compensate for meal or carbohydrate intake. The manual prescribing process involves the user estimating carbohydrate intake and using a bolus calculator, which is a burdensome and error-prone task for many less skilled users. Summary of the Invention

[0004] This Summary is provided to introduce some concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

[0005] In some approaches, a method may include receiving a meal notification. The meal notification may be a meal intake notification. In response to the meal intake notification, a carbohydrate compensation dose of insulin may be estimated. An insulin on-board (IOB) amount based on insulin delivery history may be estimated. A current blood glucose measurement may be obtained. A correction insulin dose may be estimated using the estimated IOB amount and the current blood glucose measurement. Once the correction insulin dose estimation is complete, the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose may be delivered. Changes in the blood glucose measurement over time may be monitored, and basal insulin may be delivered to bring the blood glucose measurement within a set blood glucose measurement range. Within a predetermined estimated time of receiving the meal notification, a determination may be made as to whether blood glucose measurements obtained within the predetermined estimated time exceeded a hyperglycemic threshold or fell below a hypoglycemic threshold. In response to blood glucose measurements obtained within a predetermined time exceeding a hyperglycemic threshold or falling below a hypoglycemic threshold, the carbohydrate compensation dose of insulin may be adapted by a predetermined factor.

[0006] In another approach, another method includes obtaining a user's total daily insulin, the user's target blood glucose, and the user's current blood glucose measurement. The obtained total daily insulin can be used to estimate a carbohydrate-compensated insulin dose. The user's target blood glucose and the user's blood glucose measurement can be used to estimate a correction insulin dose. The carbohydrate-compensated insulin dose and the correction insulin dose can be combined for a total bolus to be delivered. The user's glycemic status and other information related to the user's blood glucose can be monitored. Based on a determination of the user's glycemic status and other information related to the user's blood glucose, it can be determined whether the total bolus under-delivered insulin. Based on a determination that the total bolus under-delivered insulin, it can be determined whether the carbohydrate compensation estimation algorithm should be updated. Based on a determination of the user's glycemic status and other information related to the user's blood glucose, future carbohydrate-compensated insulin dose updates can be generated.

[0007] In a further approach, a drug delivery device is provided that includes a memory and a controller. The memory can store programming code, and the controller can be configured to execute the programming code. By executing the programming code, the controller can be configured to receive a meal notification, which is a notification of the ingestion of a meal. In response to the meal ingestion notification, a carbohydrate compensation dose of insulin can be estimated. An insulin on-board (IOB) amount can be estimated based on an insulin delivery history. A current blood glucose measurement can be obtained, and a correction insulin dose can be estimated using the IOB estimate and the current blood glucose measurement. Once the correction insulin dose estimation is complete, the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose can be delivered. Changes in the blood glucose measurement over time can be monitored. Basal insulin can be delivered to bring the blood glucose measurement within a set blood glucose measurement range. Within a predetermined time period after receiving the meal notification, a determination can be made as to whether the blood glucose measurements obtained within the predetermined time period exceeded a hyperglycemic threshold or fell below a hypoglycemic threshold. In response to determining whether the blood glucose measurements obtained within the predetermined time period exceeded a hyperglycemic threshold or fell below a hypoglycemic threshold, the carbohydrate compensation dose of insulin can be adapted by a predetermined factor. [Brief explanation of the drawings]

[0008] In the drawings, like reference characters generally refer to the same parts throughout the different views. In the following description, various embodiments of the present disclosure are described with reference to the following drawings:

[0009] [Figure 1A] 10 shows a flow diagram of an exemplary process for determining the dosage of a bolus infusion in response to a meal announcement. [Figure 1B] 10 illustrates a flow diagram of an alternative exemplary process for responding to a meal announcement. [Figure 2]1A and 1B illustrate sub-processes that can be used in the exemplary process of FIGS. [Figure 3A] 1A and 1B illustrate a process that can be used in the exemplary process of FIGS. 1A and 1B to estimate a correction insulin dose that takes into account the amount of insulin on-board for a user. [Figure 3B] 1 shows examples of different timelines for responding to delivery of a carbohydrate compensation dose of insulin or an insulin correction bolus. [Figure 3C] 1 shows examples of different timelines for responding to delivery of a carbohydrate compensation dose of insulin or an insulin correction bolus. [Figure 3D] 1 shows examples of different timelines for responding to delivery of a carbohydrate compensation dose of insulin or an insulin correction bolus. [Figure 4] FIG. 1B shows an example of a process for determining long-term updates to carbohydrate-compensated insulin doses that can be used in the example process described in FIGS. 1A and 1B. [Figure 5] 1 illustrates a functional block diagram of an example system suitable for implementing the example processes and techniques described herein. [Figure 6] 1 illustrates an example of a graphical user interface that can be used with the disclosed techniques and devices. DETAILED DESCRIPTION OF THE INVENTION

[0010] Systems, devices, computer-readable media, and methods according to the present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, which illustrate one or more embodiments. The systems, devices, and methods may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the methods and devices to those skilled in the art. Each of the systems, devices, and methods disclosed herein offers one or more advantages over conventional systems, components, and methods.

[0011] Various embodiments provide methods, systems, devices, and computer-readable media for responding to inputs provided by sensors, such as analyte sensors, and users of automated drug delivery systems. The various devices and sensors that can be used to implement some of the illustrative examples can also be used to implement different treatment regimens using different drugs than those described in the illustrative examples.

[0012] In one embodiment, the disclosed method, system device, or computer-readable medium may perform actions related to a user's glycemic management in response to the user's consumption of a meal.

[0013] The disclosed embodiments provide techniques that can be used with any additional algorithms or computer applications that manage blood glucose levels and insulin therapy. These algorithms and computer applications may be collectively referred to as "drug delivery algorithms" or "drug delivery applications," and may be operable to deliver different categories of drugs (or medications), such as chemotherapy drugs, pain medications, diabetes medications (e.g., insulin and / or glucagon), blood pressure medications, etc.

[0014] One type of drug delivery system (MDA) may include an "artificial pancreas" algorithm-based system, or more generally, an artificial pancreas (AP) application. For ease of discussion, computer programs and computer applications implementing a drug delivery algorithm or application may be referred to as an "AP application." The AP application may be configured to provide automatic insulin delivery based on a blood glucose sensor input, such as a signal received from an analyte sensor such as a continuous blood glucose monitor. In one example, the artificial pancreas (AP) application, when executed by a processor, can enable monitoring of a user's blood glucose measurement, determine an appropriate insulin level for the user based on the monitored glucose value (e.g., blood glucose concentration or blood glucose measurement) and other information, such as information regarding carbohydrate intake, exercise duration, meal times, etc., and take action to maintain the user's blood glucose level within an appropriate range. A target blood glucose level for a particular user may alternatively be a range of blood glucose measurements appropriate for the particular user. For example, a target blood glucose measurement may be acceptable if it falls within a range of 80 mg / dL to 120 mg / dL, a range that meets clinical therapeutic standards for diabetes treatment. Additionally, the AP application described herein can determine if the user's blood glucose is wandering within a hypoglycemic or hyperglycemic range.

[0015] As described in more detail with reference to the embodiments of Figures 1A-4, the automatic drug delivery system can be configured to monitor a user's blood glucose readings, input from a user interface or a meal detection and response algorithm executed by a processor of the wearable automatic drug delivery device. The input from the user interface or meal detection and response algorithm can be an indication that the user has consumed or is about to consume a meal. The automatic drug delivery system can utilize the monitored information and / or input to determine a different medication dose to compensate for the intake of the meal. The determined response to the intake of the meal can be a determination of an insulin dose intended to compensate for the increase in blood glucose as a result of carbohydrates in the consumed meal.

[0016] Typically, when responding to a meal, the AP application's algorithms implement a conservative approach due to the uncertainty of the actual intake of a meal built into their respective meal detection algorithms, without using the functionality illustrated in the following examples. In contrast to this conservative approach, the disclosed examples can implement aggressive delivery of insulin to more quickly, yet appropriately, compensate for the consumption of a meal that adheres to a lowered or reduced safety constraint. The following examples provide an AP application configured with a meal detection and response algorithm operable to modify post-meal safety constraints to enable delivery of an insulin dose to the user that more quickly compensates for the consumption of the meal. As described in more detail below, the example meal detection and response algorithm can indicate the intake of a meal, which allows the AP application to modify the safety constraint settings for determining the meal bolus, thereby enabling more rapid compensation for the meal.

[0017] An advantage of the disclosed embodiments is an automated drug delivery (ADD) system that is capable of determining that a meal has been consumed and modifying safety constraints associated with the consumed meal to enable the automated insulin delivery system to administer the appropriate amount of insulin quickly and seamlessly without requiring the user to enter details about the consumed meal. Details about the consumed meal may include identification of the meal's composition (e.g., meat, starch, fruit, etc.), the estimated carbohydrate and / or calorie count in the meal, the size of the meal, the estimated calorie or carbohydrate count, etc. Using the described techniques, the system reduces the burden on the user when it is time to deliver insulin to compensate for changes in blood glucose readings as a result of consuming a meal and optimizes delivery of the correction bolus so that the user can receive the bolus more quickly and begin to lower their blood glucose readings.

[0018] It may be beneficial to explain these examples, as well as other examples of determining a correction bolus dose, in more detail with reference to the drawings.

[0019] One advantage provided is simply allowing the user to provide input that they are eating. Such input may be a simple input to a soft button presented in a graphical user interface, a voice input to a control application, etc. The meal announcement may cause the AP application to initiate a process to compensate for the intake of a meal.

[0020] Prior to the meal announcement, the AP application may have detected that the user's blood glucose was trending higher. For example, upon receiving a blood glucose measurement from an analyte sensor, which may be a blood glucose sensor, the blood glucose sensor may also provide an indication (e.g., a flag setting, a bit setting, etc.) of the direction of the trend, e.g., rising, falling, or stable, of the blood glucose measurement relative to the previously provided blood glucose measurement. The AP application may also compare the received blood glucose measurement to a target blood glucose level and indicate if the target blood glucose level has been exceeded.

[0021] FIG. 1A shows a flow diagram of an exemplary process for determining a bolus infusion dose in response to a meal notification. The example process illustrated in FIG. 1A can be implemented by an AP application executing on a processor. As shown in the example process 100 of FIG. 1A, the AP application can receive a meal notification at 110. The meal notification can be a notification of meal intake provided by a user input or an automatic meal detection algorithm. For example, the meal notification can be in response to a user touching a bolus button, a user verbally indicating a meal in a specific phrase, or a user shaking or otherwise physically interacting with the device. Alternatively, the AP application can utilize an automatic meal detection algorithm configured to determine that a meal has been consumed from one or more various inputs. In either scenario, the AP application does not require the user to enter an estimate of carbohydrates in the meal.

[0022] In response to the meal notification at 110, the AP application can obtain the user's total daily insulin (TDI), which can be based on, for example, the user's weight and / or the user's insulin delivery history.

[0023] At 120, in response to a meal notification indicating the intake of a meal, the AP application can estimate a carbohydrate compensation dose of insulin. The AP application can use the user's carbohydrate history or the user's insulin delivery history to make the estimation. Additionally, a clustering algorithm personalized to the user can be used based on one or more of the user's carbohydrate history or the user's insulin delivery history. In some examples, the carbohydrate compensation dose of insulin can be approximately 10 percent of the user's total daily insulin. At 130, the AP application can be configured to estimate an insulin on-board (IOB) amount for the user based on the user's insulin delivery history. At 140, a current blood glucose measurement can be obtained from a blood glucose sensor or from a memory coupled to the processor. At 150, a correction insulin dose can be estimated using the estimated IOB amount. Once the estimation of the correction insulin dose to be delivered is complete, the AP application can be configured to sum the estimated carbohydrate compensation dose of insulin and the correction insulin dose at 160. The summation can be adjusted based on the user's starting blood glucose, IOB, and trends in the user's blood glucose measurements. In one embodiment, the AP application can output a control signal to cause delivery immediately after the summation. As indicated at 170, changes in the blood glucose measurement can be monitored by the AP application over a period of time. The blood glucose measurement over the period of time can vary between 70 mg / dL and 180 mg / dL. The AP application can continue to deliver insulin basal doses as well as insulin correction doses to keep the blood glucose measurement within the set user target blood glucose range. At 180, the AP application can evaluate the monitored changes in the blood glucose measurement over a pre-estimated period of time to determine whether the user's blood glucose has entered a hypoglycemic region (e.g., below approximately 70 mg / dL) or a hyperglycemic region (e.g., above approximately 180 mg / dL).In response to determining that the user's blood glucose remains between the hypoglycemic and hyperglycemic regions, the AP application can determine that the result of the evaluation at 180 is "NO" and can continue monitoring the user's blood glucose at 170. Alternatively, if the determination at 180 is "YES," i.e., if it is determined that blood glucose measurements obtained within a predetermined estimated time after the bolus administration, such as 5 hours, have exceeded the hyperglycemic threshold or fallen below the hypoglycemic threshold within a predetermined estimated time period, the AP application can respond by adapting the carbohydrate compensation dose of insulin by a predetermined factor. The predetermined factor can be 5-10%, 10-15%, 5-15%, etc.

[0024] In a further example, the updated estimate of the IOB amount can be used to estimate an updated correction insulin dose, and the processor can sum the adapted carbohydrate compensation dose of insulin and the updated correction insulin dose and deliver the sum of the adapted carbohydrate compensation dose of insulin and the updated correction insulin dose once the correction insulin dose estimation is complete.

[0025] 1B shows an alternative process embodiment for responding to a meal announcement. Similar to process 100, alternative process 101 does not require input of any composition information (e.g., food items, portion sizes, etc.), location information, carbohydrate information, or any other nutritional information about the meal.

[0026] Process 101 may begin with the AP application obtaining the user's total daily insulin at 105a and obtaining the user's current blood glucose reading and target blood glucose at 105b. Steps 105a and 105b may occur sequentially or simultaneously. At step 106, the user's TDI obtained at 105a may be used to estimate a carbohydrate-compensated insulin dose. At 108, the user's TDI obtained at 105a and the user's current blood glucose reading and target blood glucose obtained at 105b may be used to estimate a correction insulin dose. Upon determining the carbohydrate-compensated insulin dose at 106 and the correction insulin dose at 108, the AP application may be operable to combine the carbohydrate-compensated insulin dose and the correction insulin dose for a total bolus. The total bolus may be delivered by the drug delivery device at 115.

[0027] After delivery of the total bolus, the AP application can continue to adapt AP application settings based on information received from the user, the analyte sensor, etc. For example, the AP application can continue to actively monitor the user's status through receipt of blood glucose measurements, blood glucose trend indicators, and other user-related metrics (e.g., calendar appointments, movement of the drug delivery device, etc.). At 125, the AP application can actively update and / or compensate different parameters of the artificial pancreas algorithm that may affect the amount of insulin to be delivered based on the monitored status and user-related metrics.

[0028] The AP application can also continue to monitor the user's blood glucose status and other information, such as other information related to the user's blood glucose, such as the user's blood glucose trend, insulin onboard, or the user's heart rate. Based on the user's blood glucose and other information, which may include both blood glucose-related information (such as blood glucose trend) and user status information (such as heart rate and oxygen saturation), the AP application can determine whether long-term measures, short-term measures, or both need to be taken. For example, the AP application can obtain and check postprandial blood glucose at 131 and provide this information to two different subprocesses that initiate long-term and short-term measures, respectively. The first subprocess for receiving the results of the postprandial blood glucose check can be 141, which implements the long-term measures (in relation to the short-term measures). At 141, an algorithm is designed to estimate the impact of the undelivered carbohydrate dose of insulin, which can then be used to adjust the reduction rate for the next meal. For example, the carbohydrate compensation bolus of insulin can be reduced by, for example, approximately 50% or 60% for a preceding meal, where the postprandial blood glucose measurement is much greater than the target blood glucose setpoint. The amount of decline in the blood glucose reading as a result of the undelivered carbohydrate compensation bolus dose can be estimated. If the estimated blood glucose reading after subtracting the estimated decline as a result of the undelivered carbohydrate compensation bolus is close to the target blood glucose setpoint, the AP application may determine that it is safe to reduce the percentage reduction for the next meal, for example, by approximately 40-50%, or more specifically, 45%, 48%, 50%, etc. Based on the determined impact of the undelivered carbohydrate compensation insulin dose, the AP application can update the algorithm for estimating the carbohydrate compensation insulin dose. For example, the algorithm's parameters or coefficients, such as insulin on board (IOB), total daily insulin (TDI), target blood glucose setpoint, insulin sensitivity, etc., can be modified.For example, if the post-meal blood glucose measurement is still below 70 mg / dL, the AP application may consider and enable a further increase in the reduction percentage for safety and increase insulin sensitivity to help reduce correction insulin delivery. Updates to the algorithm for estimating carbohydrate compensation insulin doses may be used to calculate updates to future carbohydrate compensation insulin doses. Future carbohydrate compensation insulin doses may be used for the next meal or may be used for a specific meal, such as breakfast or dinner.

[0029] A second subprocess may be implemented at 132 that may implement short-term actions (relative to the longer-term actions of the process beginning at 141), which may entail determining whether the blood glucose measurement exceeds the target blood glucose setpoint. For example, the determination at 132 may determine whether the AP application is going to be more aggressive in reducing the user's blood glucose. If the result at 132 is NO, i.e., the blood glucose measurement does not exceed the target blood glucose setpoint, process 101 returns to 131. However, if the result at 132 is "YES, the blood glucose measurement exceeds the target blood glucose setpoint," process 101 may evaluate which of two options will allow the user's blood glucose to reach the user's target blood glucose setpoint (136). For example, option 1 at 136 is to relax the constraints on the algorithm for delivery of insulin to compensate for meal consumption. As an alternative to option 1, option 2 at 134 may be implemented, for example, to determine whether a second bolus can be delivered and, if it is determined that a second bolus should be delivered, to calculate the size of the second bolus.

[0030] Depending on which option is implemented, insulin can be delivered or the delivery of insulin can be delayed so that the user's blood glucose reaches the user's target blood glucose setpoint, reflected at 155 in FIG. 1B.

[0031] Processes 100 and 101 utilize subprocesses that enable the determination of carbohydrate-compensated insulin doses. An example of such a subprocess is described in connection with Figure 2. Figure 2 shows an example of a subprocess that can be used within the example process of Figures 1A and 1B. In particular, the algorithm illustrated in Figure 2 can be used to calculate the amount of insulin needed to compensate for a meal indicated by a meal announcement.

[0032] 2, process 200 may enable estimation of a carbohydrate compensation dose of insulin based on total insulin for the day. For example, at 210, the processor may be configured to obtain the user's historical estimated carbohydrate values ​​from a database such as Glooko® data. From the user's historical blood glucose measurements, process 200 may obtain the user's carbohydrate compensation dose and average total insulin for the day at 220.

[0033] The processor may further be configured to build a linear regression model based on the daily total insulin that can be used to predict a value for the user's carbohydrate-compensated insulin dose. This prediction can be used if the user is a new user. Different methods can be used to make the prediction, such as kernel density estimation or median. Kernel density estimation is a process that can estimate the probability density function of a random variable. The kernel density estimation-derived carbohydrate-compensated insulin dose and the median-derived carbohydrate-compensated insulin dose can be based on the user's TDI. The median method can utilize the median carbohydrate-compensated insulin dose obtained from historical data or a history of average TDI values.

[0034] Additionally or optionally, at 220, process 200 can check the degree of correlation between the estimated carbohydrate insulin dose and the TDI. The AP application can use the degree of correlation between the estimated carbohydrate insulin dose and the TDI in building a regression model using either kernel density estimation from 222 or the median of the IC ratios corresponding to each TDI value at 224. Alternatively, other statistical methods, such as averaging, can be used.

[0035] In an embodiment, the data acquired at 220 is used to determine the mean bolus using either kernel density estimation 222 or median 224 .

[0036] Using the output from either the kernel density estimate 222 or the median 224, the process 200 can initialize a carbohydrate-compensated insulin dose prediction model, which can be a linear regression model related to the TDI to predict carbohydrate-compensated insulin doses for new users. The linear regression model can later be updated based on the user's postprandial performance (e.g., the user's physical ability to return their blood glucose to within their target blood glucose setpoint). For example, at 230, the AP application can estimate carbohydrate-compensated insulin using an equation such as a*TDI+b, where a is a percentage of total daily insulin (TDI) and b is the interception of this linear function that is an adjustment for TDI-related bolus prediction. It can be, for example, negative half a unit or negative one unit.

[0037] Metrics may be, for example, percentage of hyperglycemic / hypoglycemic events, time within a target blood glucose setpoint range (e.g., within 10-20% of the target blood glucose setpoint), average blood glucose readings, etc. The AP application may be configured to determine, based on the received metrics, a percentage (%) of carbohydrate-compensated insulin dose to deliver to avoid a high incidence of hypoglycemia. The high incidence of hypoglycemia may be based on user subjectivity, with an exemplary set value being approximately 50%. Alternatively, the high incidence may be a percentage (%) range, such as 50% to 100%, in increments of 10%. Metrics may further include determining the marginal benefit of reducing the percentage (%) of both hyperglycemic and hypoglycemic events and delivery percentages, where the marginal benefit is, for example, how much hyperglycemia or hypoglycemia is reduced based on the percentage of carbohydrate-compensated insulin dose.

[0038] At 230 in process 200, each user's typical dose of carbohydrate-compensated insulin calculated at 222 and the average TDI from 220 can be used as input to train a carbohydrate-compensated insulin dose prediction model as labeled at 240. For example, the output from the carbohydrate-compensated insulin dose prediction model at 240 can be a carbohydrate-compensated insulin dose calculated based on the relationship between the median carbohydrate-compensated insulin dose and the TDI.

[0039] After assessing the estimated carbohydrate compensation dose, to increase the safety of the estimated carbohydrate compensation dose, the AP application can further reduce the estimated carbohydrate compensation dose at 250 based on the output from the carbohydrate-compensated insulin dose prediction model (e.g., (a*TDI+b)). The output percentage can be used to determine a revised carbohydrate-compensated insulin dose. For example, the equation for such a calculation can be as follows: (a*TDI+b)*X_reduction+X_baseline where X_reduction represents the % reduction in the carbohydrate-compensated insulin dose that may be increased based on the carbohydrate-compensated insulin dose output, and X_reduction is the same reduction applied at all TDI values. For example, X_baseline may be 50%, while X_reduction may be 0.5, where the reduction is increased by 0.5% for each recommended insulin unit given the increased likelihood of potential over-delivery for larger bolus amounts. In one or more embodiments, the revised carbohydrate-compensated insulin dose may be an updated carbohydrate-compensated insulin dose.

[0040] In a further example, the determination of the total bolus to deliver may be performed differently depending on the type of insulin the user is using, as shown in FIG. 3A. There are known rules of thumb that can be used to assist a user in calculating the expected drop in blood glucose per unit of insulin they receive. For regular insulin, the rule of thumb may be the 1500 rule, which is a method for calculating a user's insulin sensitivity. For users of regular (or long-acting) insulin, the 1500 rule provides an estimate of how much the user's blood glucose is expected to drop for each unit of regular insulin. In one example, the number 1500 is divided by the user's daily dose of insulin, and the quotient is used in the insulin-to-blood glucose ratio. For example, if a user takes 30 units of regular insulin daily, dividing 1500 by 30 may represent the expected drop in blood glucose per unit of regular (or long-acting) insulin they receive. The quotient of this division is equal to 50. Thus, in this example, the quotient 50 means that the user's insulin sensitivity coefficient is 1:50, meaning that one unit of regular insulin will lower the respective user's blood glucose by approximately 50 mg / dL.

[0041] Alternatively, the rule of thumb may be different for short-acting insulin. For example, the rule of thumb may be the 1800 rule, which can be used to approximate a user's insulin sensitivity to short-acting insulin. The 1800 rule for a short-acting insulin user provides an estimate of how much the user's blood glucose is expected to drop for each unit of short-acting insulin. For example, if a user takes 30 units of regular insulin daily, dividing 1800 by 30 may represent the expected drop in blood glucose per unit of short-acting insulin the user receives. The quotient of this division is equal to 60. Thus, in this example, the quotient of 60 means that the user's insulin sensitivity coefficient is 1:60, meaning that one unit of short-acting insulin will lower the respective user's blood glucose by approximately 60 mg / dL. Either the 1500 rule or the 1800 rule can be used to estimate a correction insulin dose that may be sufficient to cover the gap between the starting blood glucose value and the target blood glucose setpoint.

[0042] 3A illustrates a process for estimating a correction insulin dose that takes into account the amount of insulin on-board for a user. In process 300, the AP application can estimate a correction insulin dose based on the 1800 rule, trends in blood glucose measurements from a blood glucose monitor, and trends in prior IOB. Recall that the correction insulin dose can be used as a correction for a meal insulin correction bolus.

[0043] For purposes of estimating the dose of correction insulin needed to cover the gap between the starting and target BG, the difference between the current blood glucose measurement and the target blood glucose set point can be determined by the AP application, as indicated at 310. For example, the current blood glucose measurement (i.e., BGCurrent) can be obtained from a blood glucose monitor or from a memory that stores recently received blood glucose measurements. Additionally, the user's target blood glucose set point (i.e., BGTarget) can also be retrieved from memory.

[0044] The AP application may perform a calculation of the difference between the current blood glucose measurement and the target blood glucose setpoint. At 320, the AP application may calculate a preliminary correction insulin dose in response to the difference between the current blood glucose measurement and the target blood glucose setpoint. "Preliminary" may refer to a correction insulin dose that has not yet been delivered. Depending on the type of insulin the user is using (i.e., short-acting insulin or regular / long-acting insulin), the user's insulin sensitivity may be determined using either the 1800 rule for short-acting insulin or the 1500 rule for regular insulin. The user's insulin sensitivity is determined as described above as a rule of thumb. The correction insulin dose at 320 is:

number

[0045] It is noted that a correction bolus can be used to eliminate the difference between the current blood glucose measurement and the target blood glucose setpoint, and a meal bolus or carbohydrate compensation bolus can be used to control blood glucose increases caused by carbohydrate intake. When a bolus is delivered in response to the user eating, the amount of insulin in the total bolus dose delivered is equal to the carbohydrate compensation bolus dose plus (+) the correction bolus dose minus (-) the insulin on board (IOB).

[0046] The AP application executed by the processor may be operable to adjust correction insulin doses to avoid hypoglycemia and hyperglycemia using trends in the user's blood glucose measurements provided by the blood glucose monitor. At 330, the AP application may adjust a preliminary correction insulin dose based on trends in blood glucose measurements received over a predetermined period of time. In one embodiment, the predetermined period is measured over several minutes. A blood glucose sensor, such as a CGM, may provide an indication of the trend. The AP application may, in some cases, interpret the indication of the trend and cause the presentation of a trend indicator icon on the graphical user interface. The trend indicator icon may be, for example, an up arrow (i.e., a vertical arrow pointing upward), a down arrow (i.e., a vertical arrow pointing downward), a dash (indicating a stable or flat trend), an arrow at a 45-degree upward or downward angle, etc. The angle of the up or down arrow may correspond to the rate or slope of change in the determined or estimated blood glucose value. For example, a 60-degree upward arrow may indicate a more rapid change in blood glucose than a 30-degree upward arrow displayed on the graphical user interface. At 330, for example, if the blood glucose trend is downward, the correction insulin dose may be reduced by X% (which may be applied as a decimal). Alternatively, if the blood glucose trend is upward, the correction insulin dose may be increased by Y%, where X and Y may be different and may be, for example, 10% to 70%. By executing the equation, the adjusted preliminary correction insulin dose may be output as the estimated correction insulin dose.

[0047] An exemplary equation for the adjusted correction insulin dose may be as follows:

number

[0048] After obtaining the adjusted correction insulin dose, the AP application can determine a total bolus dose. For example, the AP application can be operable to combine the adjusted correction insulin with a reduced carbohydrate compensation insulin dose, which can be equivalent to adding the adjusted correction insulin dose to the carbohydrate compensation insulin dose.

[0049] Different options can be provided to allow the AP application to determine the amount of basal insulin to deliver so that the blood glucose measurement falls within a pre-estimated blood glucose measurement range. For example, by determining whether the user's post-prandial blood glucose measurement is higher or lower than the user's target blood glucose setpoint, an algorithm within the AP application can adjust basal insulin over a period of time to proactively compensate for under- and over-bolus administration. It can be assumed that any initial bolus delivery that is above or below the optimal value will be compensated up to the maximum possible compensation amount.

[0050] In the example of FIG. 3B, a user's postprandial blood glucose measurement can be evaluated in relation to the user's target blood glucose setpoint. For example, the AP application can record meal notification times and obtain postprandial blood glucose measurements (and blood glucose trend indicators) from a blood glucose sensor. The AP application can retrieve the user's target blood glucose setpoint from memory coupled to a processor running the AP application. The AP application can compare the received blood glucose measurement with the retrieved target blood glucose setpoint for the user. Additionally, the AP application can determine whether the blood glucose trend indicator is trending upward or downward.

[0051] In the example of Figure 3B, the logic may proceed as follows: if the post-meal blood glucose measurement is less than (<) the target blood glucose setpoint, the AP application may withhold basal insulin for a peak time of insulin delivery, which may be approximately 1.5 hours, until basal insulin rises above (Δ_BG measured in mg / dL + up to a pre-estimated minimum threshold). The pre-estimated minimum compensation threshold may be, for example, 50 mg / dL, 55.0 mg / dL, 67.25 mg / dL, etc. Additionally or alternatively, the minimum threshold may be modifiable based on the user's insulin sensitivity, etc.

[0052] If the postprandial BG is greater than (>) the target BG, the AP application can be configured to deliver approximately four times the amount of basal insulin scheduled to be delivered throughout the peak time of insulin delivery relative to the meal over some period of time, e.g., more than 1.5 hours, until the BG reaches a threshold, e.g., (Δ_BG measured in mg / dL—up to a pre-estimated maximum compensation threshold). For example, the AP application can begin delivering this increased basal insulin dose for a set period of time (e.g., peak time for insulin delivery). Delivery of the basal dose can begin after delivery of the sum of the estimated carbohydrate compensation dose and correction insulin dose of insulin.

[0053] In one variation, the AP application can utilize a blood glucose trend indicator to determine whether the total bolus under-delivered insulin. For example, the AP application can receive a blood glucose trend indicator from a blood glucose sensor. The AP application can evaluate the blood glucose trend indicator in relation to the user's target blood glucose setpoint. The evaluation of the user's blood glucose trend indicator can indicate that the user's blood glucose measurement is trending upward toward or above the user's target blood glucose setpoint. Based on the results of the evaluation, the AP application can determine that the total bolus under-delivered insulin and generate an indication that the total bolus under-delivered insulin. Conversely, the AP application can evaluate the user's blood glucose measurement in relation to the user's target blood glucose setpoint. Based on the results of the evaluation that indicate the user's blood glucose measurement is less insulin than the user's target blood glucose setpoint, the AP application can determine that the total bolus did not under-deliver insulin and generate an indication that the total bolus did not under-deliver insulin.

[0054] Alternatively, FIG. 3C illustrates another example of logic for delivering basal insulin to bring a blood glucose measurement within a set blood glucose measurement range. In this example, the AP application may be operable to cause the wearable automatic drug delivery device to initiate delivery of a basal dose of insulin that is modifiable based on relaxed safety constraints after delivery of the sum of the estimated carbohydrate compensation dose and correction insulin dose of insulin. For example, in FIG. 3C, if the postprandial blood glucose measurement is greater than (>) the target blood glucose setpoint, the AP application may prompt a relaxation of the algorithmic constraints of the basal insulin compensation, for example, from 4 times to 4+n times. "n" may be a value determined based on the user's blood glucose setpoint. "n" may be determined by the following formula:

number

[0055] Yet another example of determining a basal insulin dose to deliver to bring a user's blood glucose measurement within a set blood glucose measurement range is shown in the example of FIG. 3D. The exemplary process of FIG. 3D can be implemented when the postprandial BG is higher than the target BG. In instances where the postprandial BG is higher than the target BG after a set period of time following ingestion of a meal, the AP application can be operable to deliver a second bolus XX hours after delivery of the initial bolus to compensate for carbohydrates at the time of ingestion of the meal. In an example, the AP application can trigger delivery of the second, or secondary, bolus a set period of time (shown as XX) after delivery of the sum of the estimated carbohydrate compensation dose and correction insulin dose of insulin. In an example, the set period of time XX can be, for example, approximately 2, 3, 4, or more hours.

[0056] The AP application can perform additional functions. In some cases, the carbohydrate-compensated insulin dose can be adapted as mentioned in the examples of Figures 1A and 1B. Details of the adaptation of the carbohydrate-compensated insulin dose by a predetermined factor can be explained with reference to Figure 4.

[0057] 4 can be viewed as a long-term update of carbohydrate-compensated insulin doses based on past hypoglycemic and hyperglycemic events for a future bolus. The update can be applied to the next bolus, which may include a carbohydrate-compensated insulin dose.

[0058] In one operational example, when a carbohydrate-compensated insulin dose that can be considered a bolus is delivered, the AP application can deliver only a partial dose of the carbohydrate-compensated insulin dose. For example, the AP application can reserve a percentage, such as 60 to 80 percent, of the estimated carbohydrate-compensated insulin dose as a reserve dose. The partial dose and the reserve dose, when aggregated, form the total insulin amount within the estimated carbohydrate-compensated insulin dose. The estimated carbohydrate-compensated insulin dose estimate can be confirmed and evaluated according to process 400. For example, delivering a reduced or partial dose of the estimated carbohydrate-compensated insulin dose allows the AP application to determine whether the user's body's response to insulin can still compensate for carbohydrates from an ingested meal. Furthermore, delivering only a single portion provides the benefit of ensuring that the AP application does not over-deliver insulin to the user.

[0059] In process 400, the AP application can monitor a user's postprandial blood glucose by obtaining a blood glucose measurement from a blood glucose sensor, as indicated at 410. At 410, the AP application can be configured to receive a blood glucose measurement from a continuous blood glucose monitor, such as approximately every five minutes. In further embodiments, the AP application can also receive blood glucose trend indicators and other information. At 420, the AP application can determine whether the blood glucose measurement is lower than a target blood glucose setpoint for the user. An example target blood glucose setpoint can be approximately 120 mg / dL, which can have an upper boundary, such as 140 mg / dL, and a lower boundary, such as 100 mg / dL. Based on the response at 420, the AP application can take different actions. For example, if the postprandial blood glucose measurement is lower (<) than the target blood glucose setpoint, the process can proceed to 430. At 430, the AP application can update the estimated carbohydrate-compensated insulin dose by decreasing the estimated carbohydrate-compensated insulin dose by a pre-estimated percentage value, such as 1-10%, for the next delivery of the carbohydrate-compensated insulin dose (i.e., when the next meal is ingested by the user).

[0060] Alternatively, a determination is made that the post-meal blood glucose measurement is greater than (>) the target blood glucose setpoint at 420. In response to this determination, process 400 can proceed from 420 to 425.

[0061] At 425, the AP application can determine whether the postprandial blood glucose measurement falls within a target blood glucose setpoint range by determining whether the postprandial blood glucose measurement is below (i.e., at or below) a predetermined blood glucose hyperglycemic threshold. For example, the AP application can determine whether the postprandial blood glucose measurement is below 180 mg / dL, which may be a predetermined blood glucose hyperglycemic threshold (also referred to as a "hyperglycemic threshold" or "HYPER"). If the postprandial blood glucose measurement is below the hyperglycemic threshold HYPER (e.g., 180 mg / dL, a user-specified hyperglycemic threshold, etc.), the AP application can retain the estimated carbohydrate compensation insulin dose at 435 to trigger future delivery of a meal compensation bolus dose corresponding to the estimated carbohydrate compensation insulin dose.

[0062] However, if at 425 the AP application determines that the postprandial blood glucose measurement is greater than (>) the hyperglycemic threshold HYPER despite delivery of a percentage of the estimated carbohydrate-compensated insulin dose, the AP application can proceed to 440. Because only a percentage of the estimated carbohydrate-compensated insulin dose was delivered as a bolus in response to a meal notification or announcement, additional insulin still remains to be delivered. At 440, the AP application can cause delivery of the remaining percentage of the estimated meal bolus (e.g., the remaining 40-20%).

[0063] After 440, process 400 proceeds to 450. At 450, the AP application can determine whether delivery of the remaining percentage of the estimated carbohydrate-compensated insulin dose lowered the user's blood glucose. The AP application can wait a period of time (e.g., 90-120 minutes) after delivery of the remaining percentage of the estimated carbohydrate-compensated insulin dose to allow the remaining percentage of the estimated carbohydrate-compensated insulin dose to have an effect on the user's blood glucose. After the period of time has passed, the AP application can use a subsequently received blood glucose measurement from the blood glucose monitor to determine whether the subsequent blood glucose measurement (which is a postprandial blood glucose measurement) is below the upper boundary of the target blood glucose measurement.

[0064] At 450, the AP application can compare the estimated blood glucose value to a predetermined blood glucose hyperglycemic threshold HYPER. Based on a determination from the comparison that the post-prandial blood glucose measurement is lower (<) than the hyperglycemic threshold, the process can proceed to 455. At 455, the AP application can maintain the estimated carbohydrate compensation insulin dose to trigger future delivery of a meal compensation bolus dose corresponding to the estimated carbohydrate compensation insulin dose.

[0065] Alternatively, at 450, if the blood glucose measurement is still greater than (>) the upper boundary of the target blood glucose setpoint, the AP application can proceed to 460. At 460, the AP application may be operable to update the estimated meal bolus by increasing the insulin percentage in the carbohydrate-compensated insulin dose for the next delivery.

[0066] For example, at 460, the AP application can increase the estimated carbohydrate compensation dose by a predetermined percentage of the estimated carbohydrate compensation dose in response to the estimated blood glucose value being greater than a predetermined blood glucose hyperglycemic threshold. In one example, the increased percentage can be 5%-10% for each condition iteration.

[0067] It may be useful to discuss an example of a drug delivery system that can implement the techniques described with reference to the example of FIGS. 1A-4.

[0068] FIG. 5 illustrates a functional block diagram of an embodiment of a system suitable for implementing the example processes and techniques described herein.

[0069] The automated drug delivery system 500 may implement (and / or provide functionality for) a drug delivery algorithm, such as an artificial pancreas (AP) application, for the purpose of managing or controlling the automated delivery of a drug or medication, such as insulin, to a user (e.g., to maintain euglycemia, i.e., normal glucose levels in the blood). The drug delivery system 500 may be an automated drug delivery system and may include a wearable automated drug delivery device 502, an analyte sensor 503, and a drug delivery management device (PDM) 505.

[0070] System 500 may also, in optional embodiments, include smart accessory devices 507, such as smart watches, personal assistant devices, etc., which may also communicate with other components of system 500 via either wired or wireless communication links 591-593.

[0071] The managing device 505 can be a computing device, such as a smartphone, tablet, personal diabetes management device, dedicated diabetes therapy management device, etc. In one example, the managing device (PDM) 505 can include a processor 551, a managing device memory 553, a user interface 558, and a communication device 554. The managing device 505 can include analog and / or digital circuitry that can be implemented as the processor 551 to execute processes based on programming code stored in the managing device memory 553, such as a drug delivery algorithm or application (MDA) 559, to manage a user's blood glucose level, and to control the delivery of drugs, medications, or therapeutic agents to a user, as well as other functions, such as calculating carbohydrate compensation doses, correction bolus doses, etc., as discussed above. The managing device 505 can be used to program, adjust settings, and / or control the operation of the wearable automatic drug delivery device 502 and / or analyte sensor 503 and optional smart accessory device 507.

[0072] The processor 551 may also be configured to execute programming code stored in the managing device memory 553, such as the MDA 559. The MDA 559 may be a computer application operable to deliver medication based on information received from the analyte sensor 503, the cloud-based service 511, and / or the managing device 505 or optional smart accessory device 507. The memory 553 may also store programming code for operating, for example, a user interface 558 (e.g., a touchscreen device, a camera, etc.), a communication device 554, etc. When executing the MDA 559, the processor 551 may be configured to implement indications and notifications related to meal intake, blood glucose measurements, etc. The user interface 558 may be under the control of the processor 551 and may be configured to present a graphical user interface that allows for input of meal announcements, adjusts setting selections, etc., as described above.

[0073] In certain embodiments, when MDA 559 is an artificial pancreas (AP) application, processor 551 is also configured to execute a diabetes treatment plan (which may be stored in memory) managed by MDA 559 stored in memory 553. In addition to the functions described above, when MDA 559 is an AP application, it may further provide functionality to enable processor 551 to determine carbohydrate compensation doses, correction bolus doses, and basal doses according to the diabetes treatment plan. Furthermore, as an AP application, MDA 559 provides functionality to enable processor 551 to output signals to wearable automatic drug delivery device 502 to deliver the determined bolus and basal doses as described with reference to the embodiments of FIGS. 1A-4.

[0074] The communication device 554 operates according to one or more radio frequency protocols. It may include one or more transceivers, such as transceiver A 552 and transceiver B 556, and a receiver or transmitter. In an embodiment, the transceivers 552 and 556 may be a cellular transceiver and a Bluetooth transceiver, respectively. For example, the communication device 554 may include a transceiver 552 or 556 configured to transmit and receive signals including information usable by the MDA 559.

[0075] In the exemplary system 500, the wearable automatic drug delivery device 502 may include a user interface 527, a controller 521, a drive mechanism 525, a communication device 526, a memory 523, a power supply / energy harvesting circuitry 528, a device sensor 584, and a reservoir 524. The wearable automatic drug delivery device 502 may be configured to perform and execute the processes described in the embodiments of FIGS. 1A-4 without input from the management device 505 or any smart accessory device 507. As described in more detail, the controller 521 may be operable, for example, to implement the processes of FIGS. 1A-4 and to determine the amount of insulin delivered, IOB, remaining insulin, etc. The controller 521 can solely implement the processes of FIGS. 1A-4 and determine the amount of insulin delivered, IOB, remaining insulin, etc., based on input from the analyte sensor 504, e.g., control insulin delivery.

[0076] The memory 523 may store programming code executable by the controller 521. For example, the programming code may enable the controller 521 to control the release of insulin from the reservoir 524 and the administration of a drug dose based on a signal from the MDA 529 or from an external device if the MDA 529 is configured to implement an external control signal.

[0077] Reservoir 524 may be configured to store a drug, medication, or therapeutic agent suitable for automated delivery, such as insulin, morphine, blood pressure medication, chemotherapy medication, or the like.

[0078] The device sensors 584 may include one or more of a pressure sensor, a power sensor, etc. that are communicatively coupled to the controller 521 and provide various signals. For example, the pressure sensor of the device sensors 584 may be configured to provide an indication of fluid pressure detected in a fluid path between a needle or cannula (shown in the example of FIGS. 2A and 2B) inserted into the user's body and the reservoir 524. For example, the pressure sensor may be coupled to or integral with a needle / cannula insertion component (which may be part of the drive mechanism 525), etc. In one example, the controller 521 or processor, e.g., 551, is operable to determine a drug infusion rate based on the indication of fluid pressure. The drug infusion rate may be compared to an infusion rate threshold, and the result of the comparison may be usable in determining an insulin on-board (IOB) amount or a total daily insulin (TDI) amount.

[0079] In one example, wearable automatic medication delivery device 502 includes a communication device 526, which may be a receiver, transmitter, or transceiver operating according to one or more radio frequency protocols, such as Bluetooth, Wi-Fi, a near field communication standard, a cellular standard, etc. Controller 521 may communicate with personal diabetes management device 505 and analyte sensor 503, for example, via communication device 526.

[0080] The wearable automatic drug delivery device 502 can be attached to the body of a user, such as a patient or diabetic, at an attachment location and can deliver any therapeutic agent, including any drug or medication, such as insulin, to the user at or around the attachment location. The surface of the wearable automatic drug delivery device 502 can include an adhesive to facilitate attachment to the user's skin, as described in the previous examples.

[0081] The wearable automatic drug delivery device 502 may include, for example, a reservoir 524 for storing a drug (such as insulin), a needle or cannula (not shown in this example) for drug delivery into the user's body (which may be subcutaneous, intraperitoneal, or intravenous), and a drive mechanism 525 for transferring the drug from the reservoir 524 through the needle or cannula and into the user's body. The drive mechanism 525 may be fluidly coupled to the reservoir 524 and communicatively coupled to the controller 521.

[0082] The wearable automatic drug delivery device 502 may further include a power source 528, such as a battery, a piezoelectric device, or other form of energy harvesting device, for providing power to the drive mechanism 525 and / or other components of the wearable automatic drug delivery device 502 (e.g., the controller 521, the memory 523, and the communication device 526).

[0083] In some embodiments, the wearable automatic drug delivery device 502 and / or the managing device 505 can each include a user interface 558, such as a keypad, touchscreen display, lever, light emitting diodes, buttons on the housing of the managing device 505, microphone, camera, speaker, display, etc., configured to allow a user to input information and to allow the managing device 505 to output information for presentation to the user (e.g., alarm signals, etc.). The user interface 558 can provide input, such as voice input, gestures (e.g., hand or facial) input to a camera, swipes on a touchscreen, etc., to the processor 551, which is interpreted by programming code.

[0084] If configured to communicate with an external device, such as a PDM 505 or an analyte sensor 504, the wearable automatic drug delivery device 502 can receive signals from the management device (PDM) 505 or 508 or from the analyte sensor 504 over a wired or wireless link 594. A controller 521 of the wearable automatic drug delivery device 502 can receive and process signals from the respective external device as described with reference to the embodiments of FIGS. 1A-4 and implement delivery of drugs to the user in accordance with a diabetes treatment plan or other drug delivery regimen.

[0085] In an operational embodiment, the processor 521, when executing the MDA 559, can output control signals operable to activate the drive mechanism 525 to deliver a carbohydrate compensation dose of insulin, a correction bolus, a modified basal dose, etc., as described with reference to the embodiments of Figures 1A-4.

[0086] The smart accessory device 507 may be, for example, an Apple Watch®, other wearable smart devices including eyeglasses from other manufacturers, a global positioning system-enabled wearable, a wearable fitness device, smart clothing, etc. Similar to the management device 505, the smart accessory device 507 may be configured to perform various functions, including control of the wearable automatic drug delivery device 502. For example, the smart accessory device 507 may include a communication device 574, a processor 571, a user interface 578, and a memory 573. The user interface 578 may be a graphical user interface presented on a touchscreen display of the smart accessory device 507. The memory 573 may store programming code for operating different functions of the smart accessory device 507 as well as an instance of an MDA 579. The processor 571 may execute programming code, such as the site MDA 579, to control the wearable automatic drug delivery device 502 to implement the embodiments of FIGS. 1A-4 described herein.

[0087] The analyte sensor 503 may include a controller 531, a memory 532, a sensing / measuring device 533, a user interface 537, a power source / energy harvesting circuitry 534, and a communication device 535. The analyte sensor 503 may be communicatively coupled to a processor 551 of the management device 505 or a controller 521 of the wearable automated drug delivery device 502. The memory 532 may be configured to store information and programming code, such as instances of an MDA 536.

[0088] The analyte sensor 503 may be configured to detect a number of different analytes, such as lactate, ketones, uric acid, sodium, potassium, alcohol levels, etc., and output results of the detection, such as measurements. In one example, the analyte sensor 503 may be configured to measure blood glucose levels at predetermined time intervals, such as every 5 minutes. The communication device 535 of the analyte sensor 503 may have circuitry that operates as a transceiver for communicating the measured blood glucose levels to the management device 505 via wireless link 595 or with the wearable automatic drug delivery device 502 via wireless communication link 508. Although referred to as the analyte sensor 503, the sensing / measuring device 533 of the analyte sensor 503 may include one or more additional sensing elements, such as a glucose measuring element, a heart rate monitor, a pressure sensor, etc. The controller 531 may include discrete specialized logic and / or components, an application specific integrated circuit, a microcontroller, or a processor that executes software instructions, firmware, programming instructions stored in memory (e.g., 532), or any combination thereof.

[0089] Similar to controller 521, controller 531 of analyte sensor 503 may be operable to perform many functions. For example, controller 531 may be configured by programming code stored in memory 532 to manage the collection and analysis of data detected by sensing and measuring device 533.

[0090] Although the analyte sensor 503 is depicted in FIG. 5 as separate from the wearable automatic drug delivery device 502, in various embodiments, the analyte sensor 503 and the wearable automatic drug delivery device 502 can be incorporated into the same unit. That is, in various embodiments, the sensor 503 can be part of the wearable automatic drug delivery device 502 and can be housed within the same housing as the wearable automatic drug delivery device 502 (e.g., the sensor 503, or simply the memory storing the sensing / measuring device 533 and associated programming code, can be located within or integrated into one or more components of the wearable automatic drug delivery device 502, such as the memory 523). In such an exemplary configuration, the controller 521 can be capable of implementing the process embodiments of FIGS. 1A-4 alone, without any external input from the management device 505, the cloud-based service 511, another sensor (not shown), the optional smart accessory device 507, or the like.

[0091] The communications link 515 coupling the cloud-based service 511 to each device 502, 503, 505, or 507 of the system 500 may be a cellular link, a Wi-Fi link, a Bluetooth link, or a combination thereof. Services provided by the cloud-based service 511 may include data storage for storing anonymized data such as blood glucose measurements, historical IOB or TDI, prior carbohydrate compensation doses, and other forms of data. Additionally, the cloud-based service 511 may process anonymized data from multiple users to provide generalized information related to TDI, insulin sensitivity, IOB, etc.

[0092] Wireless communication links 508, 591, 592, 593, 594, and 595 may be any type of wireless link operating using a known wireless communication standard or a proprietary standard. By way of example, wireless communication links 508, 591, 592, 593, 594, and 595 may provide a communication link based on Bluetooth®, Zigbee®, Wi-Fi, a near field communication standard, a cellular standard, or any other wireless protocol via respective communication devices 554, 574, 526, and 535.

[0093] FIG. 6 illustrates one example of a graphical user interface that can be used with the disclosed techniques and devices.

[0094] The managing device described in the previous examples can be implemented as managing device 601, which can be a dedicated computing device having a form factor similar to a smartphone or can be a smartphone operable to run a mobile computer application that implements some or all of the meal announcement features described herein. The managing device 601 can be operable to implement a graphical user interface such as 610. The graphical user interface can include user-activated inputs such as a bolus button 611 as well as other inputs.

[0095] In one example, the MDA application described with reference to the previous example may be operable to receive a meal announcement. For example, the meal announcement may be a user-provided meal intake announcement via user input or an automatic meal detection algorithm. In the example of FIG. 6 , the meal announcement may be in response to a user touching a bolus button 611. In response to user interaction with the bolus button 611, an algorithm in the MDA application may trigger the generation of a confirmation user interface 612, which is an update to the graphical user interface 610. The confirmation user interface 612 may include a confirmation button 617 to be presented to allow the user to confirm the intake of the meal. In response to confirming the meal, the confirmation user interface 612 may be modified to present a meal announcement response graphical user interface 614. The meal announcement response graphical user interface 614 may include an indicator 615 of a bolus dose that may be delivered in response to the meal announcement.

[0096] Although button 611 and confirmation button 617 in the embodiment of FIG. 6 use the term "bolus," the wording on such buttons may vary. For example, button 611 may present "Announce Meal" or "Meal Announcement," or may ask questions such as "Are you having a meal" or "Announce Meal?" Button 617 may similarly present corresponding language for confirming a meal announcement or bolus request, such as "Confirm meal announcement" adjacent to a statement such as "Would you like to start a bolus?" A default bolus size (e.g., number of units) may also be depicted within the confirmation screen or confirmation button 617. Additionally, the default bolus size may be configured in the settings portion of the application.

[0097] Software-related implementations of the techniques described herein, such as the process embodiments described with reference to Figures 1A-4, may include, but are not limited to, firmware, application-specific software, or any other type of computer-readable instructions that may be executed by one or more processors. The computer-readable instructions may be provided via a non-transitory computer-readable medium. Hardware-related implementations of the techniques described herein may include, but are not limited to, integrated circuits (ICs), application-specific ICs (ASICs), field programmable arrays (FPGAs), and / or programmable logic devices (PLDs). In some embodiments, the techniques described herein and / or any systems or components described herein may be implemented with a processor executing computer-readable instructions stored on one or more memory components.

[0098] Additionally or alternatively, although embodiments may be described in connection with closed-loop algorithm implementations, variations of the disclosed embodiments can be implemented to enable open-loop use. Open-loop implementations enable the use of various insulin delivery methods, such as smart pens, syringes, etc. For example, the disclosed AP application and algorithms may be operable to perform various functions related to open-loop operation, such as generating prompts requesting input of information such as weight or age. Similarly, insulin delivery doses can be received from a user via a user interface by the AP application or algorithm. Other open-loop actions can also be implemented by adjusting user settings, etc., within the AP application or algorithm.

[0099] Some embodiments of the disclosed devices or processes may be implemented, for example, using a storage medium, computer-readable medium, or article of manufacture that may store instructions or sets of instructions that, when executed by a machine (i.e., a processor or controller), cause the machine to perform methods and / or operations in accordance with embodiments of the present disclosure. Such a machine may include, for example, any suitable processing platform, computer platform, computer device, processing device, computer system, processing system, computer, processor, etc., and may be implemented using any suitable combination of hardware and / or software. A computer-readable medium or article may include, for example, any suitable type of memory unit, memory, memory product, memory medium, storage device, storage product, storage medium and / or storage unit, such as memory (including non-transitory memory), removable or non-removable media, erasable or non-erasable media, writable or rewritable media, digital or analog media, hard disk, floppy disk, compact disk read-only memory (CD-ROM), recordable compact disk (CD-R), rewritable compact disk (CD-RW), optical disk, magnetic media, magneto-optical media, removable memory cards or disks, various types of digital versatile disks (DVDs), tape, cassette, etc. Instructions may include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, encrypted code, programming code, etc., implemented using any suitable high-level, low-level, object-oriented, visual, compiled and / or interpreted programming language. The programming code embodied in the non-transitory computer readable medium can cause a processor, when executed, to perform functions such as those described herein.

[0100] Several embodiments of the present disclosure have been described above. However, it is expressly pointed out that the present disclosure is not limited to these embodiments, and rather, additions and modifications to those explicitly described herein are also intended to be included within the scope of the disclosed embodiments. Furthermore, it should be understood that the features of the various embodiments described herein are not mutually exclusive and, even if not expressly stated herein, may exist in various combinations and permutations without departing from the spirit and scope of the disclosed embodiments. Indeed, those skilled in the art will conceive variations, modifications, and other implementations of what is described herein without departing from the spirit and scope of the disclosed embodiments. Therefore, the disclosed embodiments should not be defined solely by the preceding illustrative description.

[0101] Program aspects of the present technology may be envisioned as "products" or "articles of manufacture" in the form of executable code and / or associated data typically carried on and embodied within some type of non-transitory machine-readable medium. Storage media include any or all of the tangible memory of a computer, processor, or the like, or its associated modules, such as various semiconductor memories, tape drives, disk drives, etc., which may provide non-transitory storage for software programming at any time. It is emphasized that the Abstract of the Disclosure is provided to enable the reader to quickly ascertain the contents of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Moreover, in the foregoing Detailed Description, various features are grouped together in a single embodiment to streamline the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in fewer than all features of a single disclosed embodiment. Accordingly, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. In the appended claims, the terms "including" and "in which" are used as the plain English equivalents of the respective terms "comprising" and "wherein." Furthermore, the terms "first," "second," "third," etc. are used merely as labels and are not intended to impose numerical requirements on their objects. The foregoing description of the embodiments has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. Many modifications and variations are possible in light of this disclosure.It is intended that the scope of the present disclosure be limited not by this detailed description, but rather by the claims appended hereto. Future filed applications claiming priority to this application may claim the disclosed subject matter differently and generally may include any set of one or more limitations as variously disclosed and otherwise demonstrated herein. The inventions disclosed herein include the following: [Aspect 1] receiving a meal notification, the meal notification being a meal intake notification; estimating a carbohydrate compensation dose of insulin in response to said meal intake notification; estimating an insulin on-board (IOB) amount based on insulin delivery history; obtaining a current blood glucose measurement; estimating a correction insulin dose using the IOB estimate and the current blood glucose measurement; once the correction insulin dose estimation is complete, delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose; monitoring changes in blood glucose measurements over time; delivering basal insulin to bring the blood glucose measurement within a set blood glucose measurement range; determining whether a blood glucose measurement obtained within a predetermined time period of receiving the meal notification exceeded a hyperglycemic threshold or fell below a hypoglycemic threshold; and adapting the carbohydrate compensation dose of insulin by a predetermined factor in response to determining whether the blood glucose measurements obtained within the predetermined time period exceed a hyperglycemic threshold or fall below a hypoglycemic threshold. [Aspect 2] estimating an updated correction insulin dose using the updated estimate of the IOB amount; 2. The method of aspect 1, further comprising, upon completion of the estimation of the updated correction insulin dose, delivering the sum of the adapted carbohydrate compensation dose of insulin and the updated correction insulin dose. [Aspect 3] estimating a carbohydrate compensation dose of insulin obtaining historical blood glucose measurements of a user; obtaining an estimated carbohydrate compensation dose and average daily total insulin for the user; training a carbohydrate-compensated insulin dose prediction model using the user's estimated carbohydrate-compensated dose and average daily total insulin; 2. The method of aspect 1, further comprising: reducing the estimated carbohydrate compensation dose based on output from the carbohydrate-compensated insulin dose prediction model. [Aspect 4] determining a typical bolus value from the user's carbohydrate compensation dose and average daily total insulin based on intermediate boluses delivered in response to previous meal announcements; and using the intermediate bolus delivered as a factor in calculating the difference between the user's total carbohydrate compensation dose and their average daily total insulin. [Aspect 5] applying a typical bolus value based on intermediate boluses delivered in response to prior meal notifications to said user's carbohydrate compensation dose and average daily total insulin within a kernel density estimation model; 4. The method of embodiment 3, further comprising: using the output of the kernel density estimation model as a coefficient in calculating the difference between the user's total carbohydrate compensation dose and their average daily total insulin. [Aspect 6] The step of estimating a correction insulin dose further comprises: determining a difference between a current blood glucose measurement and a target blood glucose setpoint; calculating a preliminary correction insulin dose; adjusting the preliminary correction insulin dose based on a trend in blood glucose measurements received over a predetermined period of time to provide the estimated correction insulin dose; and outputting the estimated correction insulin dose for delivery to a user. [Aspect 7] delivering basal insulin to bring the blood glucose measurement within a set blood glucose measurement range; 2. The method of claim 1, further comprising: initiating delivery of a basal dose of insulin a set time period after delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose. [Aspect 8] The step of delivering basal insulin to bring the blood glucose measurement within a set blood glucose measurement range further comprises: 2. The method of claim 1, further comprising, after delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose, initiating delivery of a modified basal dose of insulin based on relaxed safety constraints. [Aspect 9] and when delivering basal insulin to bring the blood glucose measurement into a set blood glucose measurement range, commencing delivery of a basal dose of insulin after delivering the sum of the estimated carbohydrate-compensated dose of insulin and the correction insulin dose; 2. The method of claim 1, comprising the step of delivering a second bolus at a set time after delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose. [Aspect 10] adapting the carbohydrate compensation dose of insulin by a predetermined factor, checking post-prandial blood glucose by obtaining a blood glucose measurement from a blood glucose sensor; determining whether the blood glucose measurement is below a target blood glucose; and in response to the blood glucose measurement being lower than a target blood glucose, decreasing the estimated carbohydrate compensation dose by a preset percentage value. [Aspect 11] adapting the carbohydrate compensation dose of insulin by a predetermined factor, further comprising: delivering a partial dose of the estimated carbohydrate-compensated dose of insulin, the partial dose and the reserve dose, when taken together, comprising an amount of insulin within the estimated carbohydrate-compensated dose of insulin; checking post-prandial blood glucose by obtaining a blood glucose measurement from a blood glucose sensor; determining whether the blood glucose measurement is less than a target blood glucose setpoint; determining whether the blood glucose measurement is below a predetermined blood glucose hyperglycemic threshold in response to the blood glucose measurement being higher than the target blood glucose setpoint; delivering a backup dose of the estimated carbohydrate compensation dose of insulin in response to the blood glucose measurement being higher than the predetermined blood glucose hyperglycemic threshold; 2. The method of embodiment 1, comprising: [Aspect 12] determining whether a subsequent blood glucose measurement after delivery of the estimated carbohydrate compensation dose of insulin is below the predetermined blood glucose hyperglycemic threshold; 12. The method of claim 11, further comprising: in response to the blood glucose measurement being greater than the predetermined blood glucose hyperglycemic threshold, increasing the estimated carbohydrate compensation dose for future delivery by a predetermined percentage of the estimated carbohydrate compensation dose. [Aspect 13] obtaining a user's total daily insulin, the user's target blood glucose, and the user's current blood glucose measurement; using the obtained total daily insulin to estimate a carbohydrate-compensated insulin dose; estimating a correction insulin dose using the user's target blood glucose and the user's blood glucose measurement; combining the carbohydrate-compensated insulin dose and the correction insulin dose for a total bolus; delivering the total bolus; monitoring a user's blood glucose status and other information related to said user's blood glucose; determining whether the total bolus under-delivered insulin based on the determination of the user's blood glucose status and other information related to the user's blood glucose; determining whether to update a carbohydrate compensation estimation algorithm based on the determination that the total bolus under-delivered insulin; generating future carbohydrate-compensated insulin dose updates based on the determination of the user's blood glucose status and other information related to the user's blood glucose; A method comprising: [Aspect 14] monitoring the user's blood glucose status and other information related to the user's blood glucose, receiving a blood glucose measurement and a blood glucose trend indication from a blood glucose sensor; comparing the received blood glucose measurement to a target blood glucose setpoint for the user; determining a direction of the user's blood glucose based on whether the blood glucose trend indicator indicates an upward or downward direction for the user's blood glucose; and outputting the results of the comparison of the user's blood glucose and the determination of the direction thereof as the status of the user's blood glucose and other information related to the user's blood glucose for use in determining whether the total bolus under-delivered insulin. [Aspect 15] determining whether the total bolus under-delivered insulin, evaluating a user's blood glucose measurement received from a blood glucose sensor in relation to the user's target blood glucose setpoint; determining the total bolus under-delivered based on a result of the evaluation indicating that the user's blood glucose measurement is greater than the user's target blood glucose setpoint; generating an indication that the total bolus under-delivered insulin. [Aspect 16] determining whether the total bolus under-delivered insulin, receiving a blood glucose trend indication from a blood glucose sensor; evaluating the glycemic trend indicator in relation to a user's target glycemic setpoint; determining that the total bolus under-delivered insulin based on results of the evaluation of the blood glucose trend indicators indicating that the user's blood glucose measurements are trending toward or exceeding the user's target blood glucose setpoint; generating an indication that the total bolus under-delivered insulin. [Aspect 17] determining whether the total bolus under-delivered insulin, evaluating the user's blood glucose measurement in relation to the user's target blood glucose setpoint; determining that the total bolus did not under-deliver insulin based on a result of the evaluation indicating that the user's blood glucose measurement is below the user's target blood glucose setpoint; generating an indication that the total bolus did not under-deliver insulin. [Aspect 18] determining whether the total bolus under-delivered insulin, assessing trends in the user's blood glucose measurements relative to the user's target blood glucose setpoint; determining that the total bolus did not under-deliver insulin based on a result of the evaluation indicating that the user's blood glucose measurement is below the user's target blood glucose setpoint insulin; generating an indication that the total bolus did not under-deliver insulin. [Aspect 19] a memory for storing programming code; a controller configured to execute the programming code, wherein upon execution of the programming code by the controller: receive a meal notification, which is a notification of meal intake; estimating a carbohydrate compensation dose of insulin in response to said meal intake notification; Estimate insulin on-board (IOB) dose based on insulin delivery history, Get your current blood glucose reading, estimating a correction insulin dose using said IOB estimate and said current blood glucose measurement; delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose once the correction insulin dose estimation is complete; Monitor changes in blood glucose readings over time delivering basal insulin to bring the blood glucose measurement within a set blood glucose measurement range; determining whether a blood glucose measurement obtained within a predetermined time period of receiving the meal notification exceeded a hyperglycemic threshold or fell below a hypoglycemic threshold; and a controller configured to adapt the carbohydrate compensation dose of insulin by a predetermined coefficient in response to determining whether the blood glucose measurements obtained within the predetermined time period exceed a hyperglycemic threshold or fall below a hypoglycemic threshold. [Aspect 20] When the controller executes the programming code, it further Using the updated estimate of the IOB amount to estimate an updated correction insulin dose; A drug delivery device as described in aspect 19, configured to deliver the sum of the adapted carbohydrate compensation dose of insulin and the updated correction insulin dose at the time of completion of the estimation of the updated correction insulin dose. [Aspect 21] When the controller executes the programming code, estimating the carbohydrate compensation dose of insulin further comprises: Obtaining historical blood glucose measurements of the user; obtaining an estimated carbohydrate compensation dose and average daily total insulin for said user; Calculate the difference between the user's total carbohydrate compensation dose and their average daily total insulin; inputting said difference into a carbohydrate compensated insulin dose prediction model; 20. The method of embodiment 19, further configured to reduce the estimated carbohydrate-compensated dose based on output from the carbohydrate-compensated insulin dose prediction model. [Aspect 22] When the controller executes the programming code, it further comprises: determining a typical bolus value based on intermediate boluses delivered in response to prior meal announcements from the user's carbohydrate compensation dose and average daily total insulin; 22. The method of claim 21, wherein the method is configured to use the intermediate bolus delivered as a factor in calculating the difference between the user's total carbohydrate compensation dose and their average daily total insulin. [Aspect 23] When the controller executes the programming code, it further comprises: applying, within a kernel density estimation model, a typical bolus value based on intermediate boluses delivered in response to prior meal notifications to said user's carbohydrate compensation dose and average daily total insulin; A drug delivery device as described in aspect 21, configured to use the output of the kernel density estimation model as a coefficient in calculating the difference between the user's total carbohydrate compensation dose and their average daily total insulin. [Aspect 24] When the controller executes the programming code, estimating the carbohydrate compensation dose of insulin further comprises: determining the difference between the current blood glucose measurement and the target blood glucose setpoint; Calculate the preliminary correction insulin dose; adjusting the pre-correction insulin dose based on a trend of received blood glucose measurements over a predetermined period of time; 20. The drug delivery device of claim 19, configured to output the adjusted pre-correction insulin dose as the estimated correction insulin dose. [Aspect 25] and when delivering basal insulin to bring the blood glucose measurement within a set blood glucose measurement range, 20. The drug delivery device of claim 19, further comprising causing delivery of a basal dose of insulin after a set time has elapsed after delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose. [Aspect 26] and when delivering basal insulin to bring the blood glucose measurement into a set blood glucose measurement range, 20. The drug delivery device of claim 19, further comprising: after delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose, causing delivery of a modified basal dose of insulin based on relaxed safety constraints. [Aspect 27] and when delivering basal insulin to bring the blood glucose measurement into a set blood glucose measurement range, commencing delivery of a basal dose of insulin after delivering the sum of the estimated carbohydrate-compensated dose of insulin and the correction insulin dose; 20. The drug delivery device of claim 19, further comprising delivering a second bolus at a set time after delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose. [Aspect 28] and, when adapting the carbohydrate compensation dose of insulin by a predetermined factor, further comprising: checking postprandial blood glucose by obtaining a blood glucose reading from a blood glucose sensor; determining whether the blood glucose measurement is below a target blood glucose; 20. The drug delivery device of claim 19, further comprising: in response to the blood glucose measurement being lower than the target blood glucose, decreasing the estimated carbohydrate compensation dose by a preset percentage value. [Aspect 29] and, when adapting the carbohydrate compensation dose of insulin by a predetermined factor, further comprising: delivering a partial dose of said estimated carbohydrate-compensated dose of insulin, wherein said partial dose and reserve dose, when taken together, comprise an amount of insulin within said estimated carbohydrate-compensated dose of insulin; checking postprandial blood glucose by obtaining a blood glucose reading from a blood glucose sensor; determining whether the blood glucose measurement is less than a target blood glucose setpoint; responsive to the blood glucose measurement being higher than the target blood glucose setpoint, determining whether the blood glucose measurement is below a predetermined blood glucose hyperglycemic threshold; The drug delivery device of aspect 19, further comprising: being configured to deliver a backup dose of the estimated carbohydrate compensation dose of insulin in response to the blood glucose measurement being higher than the predetermined blood glucose hyperglycemic threshold. [Aspect 30] determining whether a subsequent blood glucose measurement after delivery of the estimated carbohydrate compensation dose of insulin is below the predetermined blood glucose hyperglycemic threshold; 20. The drug delivery device of claim 19, further comprising: increasing the estimated carbohydrate compensation dose for future delivery by a predetermined percentage of the estimated carbohydrate compensation dose in response to the blood glucose measurement being greater than the predetermined blood glucose hyperglycemic threshold.

Claims

1. receiving a meal notification, the meal notification being a meal intake notification without details regarding the meal consumed; estimating a carbohydrate compensation dose of insulin in response to said meal intake notification; estimating an insulin on-board (IOB) amount based on insulin delivery history; obtaining a current blood glucose measurement; estimating a correction insulin dose using the IOB amount and the current blood glucose measurement; once the correction insulin dose estimation is complete, delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose; monitoring changes in blood glucose measurements over time; delivering basal insulin to bring the blood glucose measurement within a set blood glucose measurement range; determining, within a predetermined time period after receiving the meal announcement, whether a blood glucose measurement obtained within the predetermined time period has exceeded a hyperglycemic threshold or fallen below a hypoglycemic threshold; and increasing or decreasing the estimated carbohydrate compensation dose of insulin by a predetermined percentage value in response to determining whether the blood glucose measurements obtained within the predetermined time period exceed a hyperglycemic threshold or fall below a hypoglycemic threshold; estimating a carbohydrate compensation dose of insulin obtaining historical blood glucose measurements of a user; obtaining a carbohydrate-compensated insulin dose for the user derived from a kernel density estimate or a median based on the user's average daily total insulin and the user's average daily total insulin; training a carbohydrate-compensated insulin dose prediction linear regression model using the user's carbohydrate-compensated dose and average daily total insulin; reducing the estimated carbohydrate compensation dose based on a percentage value output from the carbohydrate-compensated insulin dose predicting linear regression model.

2. estimating an updated correction insulin dose using the updated estimate of the IOB amount; 2. The method of claim 1, further comprising the step of delivering the sum of the increased or decreased carbohydrate compensation dose of insulin and the updated correction insulin dose upon completion of the estimation of the updated correction insulin dose.

3. determining a typical bolus value from the user's carbohydrate compensation dose and average daily total insulin based on intermediate boluses delivered in response to previous meal announcements; 10. The method of claim 1, further comprising using the intermediate bolus delivered as a factor in calculating the difference between the user's total carbohydrate compensation dose and their average daily total insulin.

4. applying, within a kernel density estimation model, a typical bolus value based on intermediate boluses delivered in response to prior meal notifications to said user's carbohydrate compensation dose and average daily total insulin; 10. The method of claim 1, further comprising: using the output of the kernel density estimation model as a coefficient in calculating the difference between the user's total carbohydrate compensation dose and their average daily total insulin.

5. The step of estimating a correction insulin dose further comprises: determining a difference between a current blood glucose measurement and a target blood glucose setpoint; calculating a preliminary correction insulin dose; adjusting the preliminary correction insulin dose based on a trend in blood glucose measurements received over a predetermined period of time to provide the estimated correction insulin dose; and outputting the estimated correction insulin dose for delivery to a user.

6. delivering basal insulin to bring the blood glucose measurement within a set blood glucose measurement range; 2. The method of claim 1, further comprising: initiating delivery of a basal dose of insulin a set time after delivery of the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose.

7. The step of delivering basal insulin to bring the blood glucose measurement within a set blood glucose measurement range further comprises:

2. The method of claim 1, further comprising: after delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose, initiating delivery of a modified basal dose of insulin based on relaxed safety constraints.

8. and when delivering basal insulin to bring the blood glucose measurement into a set blood glucose measurement range, commencing delivery of a basal dose of insulin after delivering the sum of the estimated carbohydrate-compensated dose of insulin and the correction insulin dose; 2. The method of claim 1, further comprising: delivering a second bolus at a set time after delivering the sum of the estimated carbohydrate-compensated dose of insulin and the correction insulin dose.

9. Increasing or decreasing the estimated carbohydrate compensation dose of insulin by a preset percentage value further comprises: checking post-prandial blood glucose by obtaining a blood glucose measurement from a blood glucose sensor; determining whether the blood glucose measurement is below a target blood glucose; and decreasing the estimated carbohydrate compensation dose by a preset percentage value in response to the blood glucose measurement being lower than a target blood glucose.

10. Increasing or decreasing the estimated carbohydrate compensation dose of insulin by a preset percentage value, delivering a partial dose of the estimated carbohydrate-compensated dose of insulin, wherein a reserve dose of the estimated carbohydrate-compensated dose of insulin excluding the partial dose is stockpiled; checking post-prandial blood glucose by obtaining a blood glucose measurement from a blood glucose sensor; determining whether the blood glucose measurement is less than a target blood glucose setpoint; determining whether the blood glucose measurement is below a predetermined blood glucose hyperglycemic threshold in response to the blood glucose measurement being higher than the target blood glucose setpoint; delivering the extra dose of the estimated carbohydrate compensation dose of insulin in response to the blood glucose measurement being higher than the predetermined blood glucose hyperglycemic threshold; The method of claim 1 , comprising:

11. determining whether a subsequent blood glucose measurement after delivery of the estimated carbohydrate compensation dose of insulin is below the predetermined blood glucose hyperglycemic threshold; 11. The method of claim 10, further comprising: in response to the blood glucose measurement being greater than the predetermined blood glucose hyperglycemic threshold, increasing the estimated carbohydrate compensation dose for future delivery by a predetermined percentage of the estimated carbohydrate compensation dose.

12. a memory for storing programming code; a controller configured to execute the programming code, wherein upon execution of the programming code by the controller: receiving a meal notification that is a meal intake notification without details about the meal consumed; estimating a carbohydrate compensation dose of insulin in response to said meal intake notification; estimating insulin on board (IOB) amount based on insulin delivery history; Get your current blood glucose reading, estimating a correction insulin dose using said IOB amount and said current blood glucose measurement; delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose once the correction insulin dose estimation is complete; Monitor changes in blood glucose readings over time delivering basal insulin to bring the blood glucose measurement within a set blood glucose measurement range; determining, within a predetermined time period after receiving the meal announcement, whether a blood glucose measurement obtained within the predetermined time period has exceeded a hyperglycemic threshold or fallen below a hypoglycemic threshold; a controller configured to increase or decrease the estimated carbohydrate compensation dose of insulin by a preset percentage value in response to determining whether the blood glucose measurements obtained within the preset time period exceed a hyperglycemic threshold or fall below a hypoglycemic threshold; When the controller executes the programming code, estimating the carbohydrate compensation dose of insulin further comprises: Obtaining historical blood glucose measurements of the user; obtaining a carbohydrate-compensated insulin dose for the user derived from a kernel density estimate or a median based on the user's average daily total insulin and the user's average daily total insulin; calculating the difference between said user's total carbohydrate compensation dose and average daily total insulin; inputting the difference into a linear regression model for predicting carbohydrate-compensated insulin dose; A drug delivery device configured to reduce the estimated carbohydrate-compensated dose based on a percentage value output from the carbohydrate-compensated insulin dose predicting linear regression model.

13. When the controller executes the programming code, it further using the updated estimate of the IOB amount to estimate an updated correction insulin dose; 13. The drug delivery device of claim 12, configured to deliver the sum of the increased or decreased carbohydrate compensation dose of insulin and the updated correction insulin dose upon completion of the estimation of the updated correction insulin dose.

14. When the controller executes the programming code, it further comprises: determining a typical bolus value based on intermediate boluses delivered in response to prior meal announcements from the user's carbohydrate compensation dose and average daily total insulin; 13. The drug delivery device of claim 12, configured to use the intermediate bolus delivered as a factor in calculating the difference between the user's total carbohydrate compensation dose and their average daily total insulin.

15. When the controller executes the programming code, it further comprises: applying, within a kernel density estimation model, typical bolus values ​​based on intermediate boluses delivered in response to prior meal notifications to said user's carbohydrate compensation dose and average daily total insulin; 13. The drug delivery device of claim 12, configured to use the output of the kernel density estimation model as a coefficient in calculating the difference between the user's total carbohydrate compensation dose and their average daily total insulin.

16. When the controller executes the programming code, estimating the carbohydrate compensation dose of insulin further comprises: determining the difference between the current blood glucose measurement and the target blood glucose setpoint; Calculate the preliminary correction insulin dose; adjusting the pre-correction insulin dose based on a trend of received blood glucose measurements over a predetermined period of time; 13. The drug delivery device of claim 12, configured to output the adjusted pre-correction insulin dose as the estimated correction insulin dose.

17. and when delivering basal insulin to bring the blood glucose measurement within a set blood glucose measurement range, 13. The drug delivery device of claim 12, further comprising causing delivery of a basal dose of insulin after a set time has elapsed after delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose.

18. and when delivering basal insulin to bring the blood glucose measurement into a set blood glucose measurement range, 13. The drug delivery device of claim 12, further comprising, after delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose, causing delivery of a modified basal dose of insulin based on relaxed safety constraints.

19. and when delivering basal insulin to bring the blood glucose measurement into a set blood glucose measurement range, commencing delivery of a basal dose of insulin after delivering the sum of the estimated carbohydrate-compensated dose of insulin and the correction insulin dose; 13. The drug delivery device of claim 12, further comprising delivering a second bolus at a set time after delivering the sum of the estimated carbohydrate compensation dose of insulin and the correction insulin dose.

20. and, when increasing or decreasing the estimated carbohydrate compensation dose of insulin by a preset percentage value, further comprising: checking postprandial blood glucose by obtaining a blood glucose reading from a blood glucose sensor; determining whether the blood glucose measurement is below a target blood glucose; 13. The drug delivery device of claim 12, further comprising: in response to the blood glucose measurement being lower than the target blood glucose, decreasing the estimated carbohydrate compensation dose by a preset percentage value.

21. and, when increasing or decreasing the estimated carbohydrate compensation dose of insulin by a preset percentage value, further comprising: delivering a partial dose of the estimated carbohydrate-compensated dose of insulin and storing a reserve dose of the estimated carbohydrate-compensated dose of insulin excluding the partial dose; checking postprandial blood glucose by obtaining a blood glucose reading from a blood glucose sensor; determining whether the blood glucose measurement is less than a target blood glucose setpoint; responsive to the blood glucose measurement being higher than the target blood glucose setpoint, determining whether the blood glucose measurement is below a predetermined blood glucose hyperglycemic threshold; 13. The drug delivery device of claim 12, further comprising: configured to deliver the reserve dose of the estimated carbohydrate compensation dose of insulin in response to the blood glucose measurement being higher than the predetermined blood glucose hyperglycemic threshold.

22. determining whether a subsequent blood glucose measurement after delivery of the estimated carbohydrate compensation dose of insulin is below the predetermined blood glucose hyperglycemic threshold; 22. The drug delivery device of claim 21, further comprising: in response to the blood glucose measurement being greater than the predetermined blood glucose hyperglycemic threshold, increasing the estimated carbohydrate compensation dose for future deliveries by a predetermined percentage of the estimated carbohydrate compensation dose.

Images